FDA Orange Book
Generic for Revlimid
Revlimid contains lenalidomide. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Revlimid is lenalidomide. 17 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Revlimid products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 10MG | Marketed (Rx) | AB | 18 | AB |
| capsule, oral | 15MG | Marketed (Rx) | AB | 18 | AB |
| capsule, oral | 2.5MG | Marketed (Rx) | AB | 17 | AB |
| capsule, oral | 20MG | Marketed (Rx) | AB | 18 | AB |
| capsule, oral | 25MG | Marketed (Rx) | AB | 18 | AB |
| capsule, oral | 5MG | Marketed (Rx) | AB | 18 | AB |
NDA 021880, held by BRISTOL MYERS SQUIBB. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic lenalidomide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ARROW INTERNATIONAL LTD | 201452 | AB (A-rated, therapeutically equivalent) | May 21, 2021 | 10MG, 15MG, 2.5MG, 20MG, 25MG, 5MG |
| APOTEX INC | 211022 | AB (A-rated, therapeutically equivalent) | August 30, 2022 | 10MG, 15MG, 2.5MG, 20MG, 25MG, 5MG |
| DR REDDYS LABORATORIES LTD | 209348 | AB (A-rated, therapeutically equivalent) | August 30, 2022 | 10MG, 15MG, 2.5MG, 20MG, 25MG, 5MG |
| MYLAN PHARMACEUTICALS INC | 213912 | AB (A-rated, therapeutically equivalent) | August 30, 2022 | 10MG, 15MG, 2.5MG, 20MG, 25MG, 5MG |
| ALVOGEN INC | 210480 | AB (A-rated, therapeutically equivalent) | August 31, 2022 | 10MG, 15MG, 2.5MG, 20MG, 25MG, 5MG |
| CIPLA LTD | 210435 | AB (A-rated, therapeutically equivalent) | September 6, 2022 | 10MG, 15MG, 20MG, 25MG, 5MG |
| ZYDUS PHARMACEUTICALS USA INC | 210154 | AB (A-rated, therapeutically equivalent) | September 12, 2022 | 10MG, 15MG, 2.5MG, 20MG, 25MG, 5MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 211846 | AB (A-rated, therapeutically equivalent) | February 8, 2023 | 10MG, 15MG, 2.5MG, 20MG, 25MG, 5MG |
| EUGIA PHARMA SPECIALITIES LTD | 213885 | AB (A-rated, therapeutically equivalent) | March 6, 2023 | 10MG, 15MG, 2.5MG, 20MG, 25MG, 5MG |
| CIPLA LTD | 214618 | AB (A-rated, therapeutically equivalent) | March 6, 2023 | 2.5MG |
| HETERO LABS LTD UNIT V | 212414 | AB (A-rated, therapeutically equivalent) | May 11, 2023 | 10MG, 15MG, 2.5MG, 20MG, 25MG, 5MG |
| QILU PHARMACEUTICAL CO LTD | 217265 | AB (A-rated, therapeutically equivalent) | February 22, 2024 | 10MG, 15MG, 2.5MG, 20MG, 25MG, 5MG |
| NOVUGEN ONCOLOGY SDN BHD | 217281 | AB (A-rated, therapeutically equivalent) | September 11, 2024 | 10MG, 15MG, 2.5MG, 20MG, 25MG, 5MG |
| AMNEAL EU LTD | 216213 | AB (A-rated, therapeutically equivalent) | January 31, 2025 | 10MG, 15MG, 2.5MG, 20MG, 25MG, 5MG |
| BIOCON PHARMA LTD | 215759 | AB (A-rated, therapeutically equivalent) | March 3, 2025 | 10MG, 15MG, 2.5MG, 20MG, 25MG, 5MG |
| DEVA HOLDING AS | 217554 | AB (A-rated, therapeutically equivalent) | May 22, 2025 | 10MG, 15MG, 2.5MG, 20MG, 25MG, 5MG |
| LUPIN LTD | 214398 | AB (A-rated, therapeutically equivalent) | September 16, 2025 | 10MG, 15MG, 2.5MG, 20MG, 25MG, 5MG |
| ACCORD HEALTHCARE INC | 218872 | AB (A-rated, therapeutically equivalent) | November 14, 2025 | 10MG, 15MG, 2.5MG, 20MG, 25MG, 5MG |
| CIPLA LTD | 213165 | AB (A-rated, therapeutically equivalent) | February 2, 2026 | 10MG, 15MG, 20MG, 25MG, 5MG |
Revlimid patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7465800 | April 27, 2027 | Drug substance, Drug product | None | 021880 |
| 8741929 | March 8, 2028 | Method of use | U-1983 | 021880 |
Revlimid exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-241 | Orphan drug exclusivity | May 28, 2026 | 021880 |
| ODE-245 | Orphan drug exclusivity | May 28, 2026 | 021880 |
Revlimid NDC codes
Questions
Is there a generic for Revlimid?
Yes. The generic name for Revlimid is lenalidomide. 17 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Revlimid?
The active ingredient in Revlimid is lenalidomide, per the FDA Orange Book.
When does the Revlimid patent expire?
The last patent listed for Revlimid in the Orange Book expires March 8, 2028. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.
More on Revlimid and Lenalidomide
- What is Revlimid used for?FDA label uses
- Is Revlimid a controlled substance?Federal schedule
- What is Lenalidomide used for?FDA label uses
- Is Lenalidomide a controlled substance?Federal schedule
- Thalidomide Analogs listFDA drug class
- Revlimid Medicare Part D coverageBy plan and state
- NDC 59572-402Revlimid NDC record
- NDC 59572-405Revlimid NDC record
- NDC 59572-410Revlimid NDC record